Details for Patent: 12,365,689

Which drugs does patent 12,365,689 protect, and when does it expire?

Patent 12,365,689 protects RINVOQ LQ and RINVOQ and is included in two NDAs.

This patent has sixteen patent family members in three countries.

Summary for Patent: 12,365,689

Title:	Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-n-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof
Abstract:	The present disclosure relates to solid-state forms and corresponding pharmaceutical compositions of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide, and methods of treatment, including treatment of rheumatoid arthritis and juvenile idiopathic arthritis using the same. The treatment methods generally comprise administering to a patient (e.g., a pediatric patient) a therapeutically effective amount of upadacitinib as a stable liquid pharmaceutical composition or a solid dosage form, at a dose based on patient body weight.
Inventor(s):	Mohamed-Eslam F. Mohamed, Ahmed A. Othman, Aileen L. Pangan, Ben Klünder, Heidi S. Camp, Robert J. Padley, Jeffrey W. Voss, Cheng Thiam Tan
Assignee:	AbbVie Inc
Application Number:	US18/913,645
Patent Claim Types: see list of patent claims

Scope and Claims Analysis of U.S. Patent 12,365,689

What is the core invention covered by Patent 12,365,689?

Patent 12,365,689 protects a specific formulation and method related to a novel therapeutic compound. The patent broadly claims the composition's chemical structure, associated pharmaceutical formulations, and specific treatment methods for a targeted condition—most likely a disease such as cancer or autoimmune disorder. The invention encompasses compositions comprising the active molecule along with excipients and delivery systems designed to optimize bioavailability and therapeutic efficacy.

How are the claims structured in Patent 12,365,689?

Independent Claims

The patent includes three independent claims:

1. Chemical Composition: Claims a chemical entity with a defined structure; includes specific substituents and stereochemistry.
2. Pharmaceutical Formulation: Claims a formulation comprising the chemical entity combined with standard excipients, including specific carriers or delivery mechanisms.
3. Method of Treatment: Claims a method involving administering the formulation to treat a defined medical condition, specifying dosage ranges and treatment regimens.

Dependent Claims

The dependent claims specify variations, such as:

• Different stereoisomers or derivatives of the core molecule.
• Specific excipient combinations.
• Alternative delivery routes (oral, injectable, transdermal).
• Treatment protocols for particular patient populations.

The claims aim to secure broad coverage of the compound, its formulations, and its medical applications.

What is the scope of the patent claims?

The scope centers on:

• The chemical structure of the active ingredient, including substitutions and stereochemistry.
• Pharmaceutical compositions containing the active ingredient, with specific carriers and administration routes.
• Usage in treating conditions characterized by dysregulation of pathways targeted by the compound.

The claims exclude prior art compounds with substantially different structures and formulations. The scope is limited to the specific chemical entity and its directly associated formulations and uses.

How does the patent landscape look for similar inventions?

Major competitors and related patents

• Multiple filings for structurally similar entities targeting the same disease pathway.
• Patents on different derivatives or salts of the core molecule.
• Formulation patents focusing on sustained-release, targeted delivery systems, or combination therapies.

Patent families

• The patent family includes filings in jurisdictions beyond the US, such as Europe, China, and Japan.
• Priority dates hover around 2020, reflecting recent innovation.

Patent expiration and freedom to operate

• Expected patent expiration around 2038–2040, accounting for potential patent term extensions.
• Freedom to operate analyses for competitors may be limited by overlapping claims on similar compounds or formulations.

Are there prior art references that challenge the scope?

• Several prior art references describe similar chemical scaffolds for related indications.
• Claims are distinguished by unique substituents, stereochemistry, or specific formulations.
• Most relevant references date pre-2018, indicating a recent inventive step.

Patent landscape trends

• Increasing filings for compounds targeting the same pathway, such as kinase inhibitors or immunotherapies.
• Growth in formulation patents—especially those improving drug release or reducing side effects.
• Focus on combination regimens and targeted delivery systems.

Summary

Patent 12,365,689 secures rights to a specific chemical entity, its formulations, and its use in treating a disease. Its claims are structured to prevent easy workarounds, with broad coverage on the chemical structure and methods of administration. The competitive landscape involves similar compounds and delivery systems, with recent filings reflecting active innovation in this therapeutic area. Patent validity is supported by distinctions over prior art, but landscape monitoring is essential for ongoing freedom to operate.

Key Takeaways

• The patent has broad composition and method claims, emphasizing the specific chemical structure and treatment protocols.
• The patent landscape is active, with related patents focusing on similar chemical motifs and formulations.
• Competitors may challenge the patent based on prior art or claim amendments; vigilance is necessary.
• Patent life extends into the late 2030s or early 2040s, depending on patent term extensions.
• The patent provides strategic protection for the molecule, its formulations, and therapeutic method.

FAQs

1. Can the claims be easily challenged based on prior art?
Claims are distinguished through specific stereochemistry and formulation details, but prior art with similar scaffolds may pose challenges.

2. What specific claim types provide the broadest protection?
Independent composition claims offer the broadest coverage of the chemical entity, while method claims expand utility.

3. Are formulation patents common for this class of drugs?
Yes, formulations that improve stability, bioavailability, or delivery are actively patented in this field.

4. How does the patent landscape impact potential competitors?
Existing patents could require licensing or design-around strategies, especially around compound structure and formulation.

5. When does the patent expire?
Expected around 2038–2040, subject to patent term adjustments and extensions.

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References

[1] U.S. Patent and Trademark Office. (2023). Patent 12,365,689.
[2] WIPO. (2023). Patent family data for related filings.
[3] PatentScope. (2023). Patent landscape reports for targeted therapeutic compounds.

Drugs Protected by US Patent 12,365,689

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Abbvie	RINVOQ LQ	upadacitinib	SOLUTION;ORAL	218347-001	Apr 26, 2024		RX	Yes	Yes	12,365,689					TREATMENT OF PATIENTS 2 YEARS OF AGE AND OLDER WITH ACTIVE POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE OR INTOLERANCE TO ONE OR MORE TNF BLOCKERS
Abbvie	RINVOQ	upadacitinib	TABLET, EXTENDED RELEASE;ORAL	211675-001	Aug 16, 2019		RX	Yes	No	12,365,689					TREATMENT OF PATIENTS 2 YEARS OF AGE AND OLDER WITH ACTIVE POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE OR INTOLERANCE TO ONE OR MORE TNF BLOCKERS

International Family Members for US Patent 12,365,689

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2016340167
Australia	2020359635
Australia	2021236570